A Cohort Study of Conversion From Aranesp® to NESP® for the Treatment of Anemia in Dialysis Patients

May 31, 2018 updated by: Dr. Mok Ming Yee, The University of Hong Kong
This is a prospective single-arm open-labeled cohort study on dialysis patients of the conversion from Aranesp® to NESP® for the treatment of anemia. The primary outcome of the study is the haemoglobin level after conversion to NESP® after 6 months. Secondary outcomes include the variability in haemoglobin level, average weekly dose of erythropoietin, safety profile of NESP®, patients' subjective assessment of fatigue and injection pain after the conversion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently in Hong Kong, Aranesp®, manufactured by Amgen® is the only available Darbepoetin alpha licensed. NESP®, a Darbepoetin alpha agent manufactured by Kirin®, will be replacing Aranesp®.It is important to evaluate the therapeutic equivalence of the two agents, and its efficacy, tolerability and safety profile in the treatment of anemia in dialysis patients. Moreover, a new maximum preparation of NESP 120® microgram will be available to replace the Aranesp® 100 microgram prefilled syringe at the same cost. This larger Darbepoetin alpha preparation may allow extension of dosing intervals. This may subsequently allow cost saving and better convenience to medical staff and patients.

The objectives of this project are:

  1. To investigate the effectiveness of NESP® in the achieving a stable anemia control in chronic dialysis patients with the same dose conversion from Aranesp®
  2. To investigate the effectiveness of increasing the dosing interval of NESP® (but maintaining the same total dose) in sustaining a stable anemia control in chronic dialysis patients

  3. To explore the possibility of cost saving in administering a larger dose NESP® but at an extended interval

    Patients will be divided into 3 groups.

    Group A. Same dose conversion group

    • Patients on stable low dose Aranesp® (on 20mcg preparations or on 40mcg every 2 weeks or less) will be converted to the same dose of NESP®

    Group B. Attempt extension of dosing interval with higher dose of NESP® preparations

    • Patients on stable dose of Aranesp® will be converted to higher dose preparation of NESP® (40 or 120 mcg preparations) with extended dosing intervals.

    Group C. Attempt dosage saving with 120 mcg preparation

    • Patients on Aranesp® 100mcg will be switched to the NESP® 120mcg preparation with slight increase in dosing interval

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Division of Nephrology, Department of Medicine, Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult Chinese patients (age greater than or equal to 18)
  • on long-term dialysis for at least 3 months
  • on Aranesp® treatment for at least 3 months
  • stable hemoglobin level within the range of 9 to12 g/dL, on the same stable dose of Aranesp® within the past 2 months.
  • Minimum weekly kT/V of 1.7 for peritoneal dialysis patients and 1.2 per haemodialysis session for haemodialysis patients
  • Able to give informed consent

Exclusion Criteria:

Presence of

  • thalassaemia
  • haematological diseases
  • severe hyperparathyroidism (PTH >90 pmol/L)
  • iron, vitamin B12 or folate deficiency
  • uncontrolled malignancy
  • active blood loss or hemolysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Darbepoetin alfa (NESP®) same dose
Patients on stable low dose Aranesp® (darbepoetin alfa manufactured by Amgen®) (on 20mcg preparations or on 40mcg every 2 weeks or less) will be converted to the same dose of NESP® (darbepoetin alfa manufactured by Kirin®)
Other: Darbepoetin alfa
Conversion from Aranesp® to NESP®
Other Names:
  • NESP
Experimental: Extended dosing Darbepoetin alfa (NESP®)
Patients on stable dose of Aranesp® (darbepoetin alfa manufactured by Amgen®) will be converted to higher dose preparation of NESP® (darbepoetin alfa manufactured by Kirin®) 40 or 120 mcg preparations) with extended dosing intervals. The total dose of Darbepoetin alpha remains the same.
Other: Darbepoetin alfa
Conversion from Aranesp® to NESP®
Other Names:
  • NESP
Experimental: Darbepoetin alfa (NESP®) 120mcg
Patients on Aranesp® 100 mcg preparation (darbepoetin alfa manufactured by Amgen®) will be switched to the NESP® (darbepoetin alfa manufactured by Kirin®)120mcg preparation with slight increase in dosing interval according to the conversion
Other: Darbepoetin alfa
Conversion from Aranesp® to NESP®
Other Names:
  • NESP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Haemoglobin
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variability in haemoglobin level
Time Frame: 6 months
6 months
average weekly dose of erythropoietin
Time Frame: 6 months
6 months
safety profile of NESP
Time Frame: 6 months
Blood pressure, Questionnaire on the occurrence of side-effects such as seizure, pure red cell aplasia, etc.
6 months
Subjective assessment of fatigue
Time Frame: 6 months
Visual Analogue Fatigue Scale
6 months
Subjective assessment of pain
Time Frame: 6 months
Numeric Pain Numeric Pain Rating Scale
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Maggie Ming Yee Mok, MBBS FHKAM, Queen Mary Hosptial, the University of Hong KOng
  • Study Director: Tak Mao Chan, MBBS FRCP, Queen Mary Hospital, the University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1.2 18thApril, 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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